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Abstract:

An anesthesia administration system is provided that provides gaseous
anesthesia to a patient's nose while providing access to a patient's
mouth, the system comprising a face mask having an integrally formed gas
inlet means, an integrally formed gas outlet means, and an integrally
formed gas sampling means.

Claims:

1. An anesthesia administration system for administering a gaseous
anesthesia to a person in need thereof, the administration system
comprising a) a face mask having an inner surface and an outer surface,
said face mask being configured for placement over the nose but not the
mouth of the person receiving anesthesia to define a nasal breathing
plenum between the person's nose and the inner surface of said face mask,
the face mask having an integrally formed gas inlet means, and an
integrally formed gas outlet means, and an integrally formed gas sample
access means; b) means for delivering a gaseous anesthesia to said nasal
breathing plenum through said integrally formed gas inlet means; c) means
for removing gas in said nasal breathing plenum through said integrally
formed gas outlet means; and d) means for accessing said integrally
formed gas sample access means; whereby said anesthesia administration
system is suitable for use in administering gaseous anesthesia to an
individual undergoing a medical or dental procedure, while simultaneously
allowing sampling of the gas within said nasal breathing plenum.

2. The anesthesia administration system of claim 1 wherein said
integrally formed gas inlet means is substantially straight.

3. The anesthesia administration system of claim 2 wherein said
integrally formed gas inlet means is substantially vertical relative to
the orientation of said face mask.

4. The anesthesia administration system of claim 1 wherein said
integrally formed gas outlet means is substantially straight.

5. The anesthesia administration system of claim 4 wherein said
integrally formed gas outlet means is substantially vertical relative to
the orientation of said face mask.

6. The anesthesia administration system of claim 1 wherein said
integrally formed gas sample access means is directed substantially
forward of the patient receiving said anesthesia.

7. The anesthesia administration system of claim 1 being operable in the
absence of one or more cannulae for delivering said gaseous anesthesia
into the nostrils of the patient.

8. The anesthesia administration system of claim 1 wherein the face mask
does not include valves.

9. The anesthesia administration system of claim 1, wherein the gas
sample access means is substantially vertical relative to the orientation
of said face mask

10. The anesthesia administration system of claim 1, wherein the gas
outlet means is sized smaller than gas inlet means.

11. A device for use in administering gaseous anesthesia to a patient in
need thereof, the device comprising pumping gas anesthesia gas through a
face mask having an inner surface and an outer surface, said face mask
being suitable for placement over the nose but not the mouth of the
person receiving anesthesia to define a nasal breathing plenum between
the person's nose and the inner surface of said face mask, the face mask
having an integrally formed gas inlet means, an integrally formed gas
outlet means, and an integrally formed gas sample access means; wherein
said face mask can be operatively coupled to a gas delivery and removal
system, whereby gaseous anesthesia can be delivered to said patient
through said gas inlet means and removed through said gas outlet means,
while maintaining a positive gas pressure at the patient's nose.

12. A method for administering gaseous anesthesia to a patient in need
thereof and under positive gas pressure at the patient's nose, the method
comprising supplying gaseous anesthesia under pressure via gas inlet
tubing to a face mask, wherein the face mask has an inner surface and an
outer surface, said face mask being suitable for placement over the nose
but not the mouth of the patient receiving anesthesia to define a nasal
breathing plenum between the patient's nose and the inner surface of said
face mask, the face mask having an integrally formed gas inlet means, an
integrally formed gas outlet means, and an integrally formed gas sample
access means; where the gas outlet means is sized smaller than gas inlet
means; and said face mask being capable of operative coupling to a gas
delivery and removal system.

Description:

[0001] This application claims the benefit of Provisional Application No.
61/702,047, filed Mar. 17, 2012, which is incorporated herein by
reference in its entirety.

TECHNICAL FIELD OF THE INVENTION

[0002] The present invention relates to a face mask for use in providing
gaseous anesthesia to a person in need thereof. More particularly the
present invention relates to a face mask for use in providing gaseous
anesthesia to a person need thereof while such person is undergoing a
dental or medical procedure requiring access to the person's mouth.

BACKGROUND OF THE INVENTION

[0003] The use of gaseous anesthesia in the medical and dental arts is
well known. Such anesthesia is used to provide sedation of a patient
during a medical, podiatric, or dental procedure that may be
uncomfortable for a patient in full wakefulness. For example, nitrous
oxide is a common gaseous anesthetic for use in certain dental
procedures. The capability exists for trained medical professionals to
provide such anesthesia in professional offices outside a hospital
environment.

[0004] Thus most dental offices include an anesthesia administration
system for administering gaseous anesthesia to a patient in need thereof.
Such a system typically comprises a source of gaseous anesthesia, a face
mask to be fitted over the nose of the patient, and means for conveying
the gaseous anesthetic from the source to the face mask, where it will be
inhaled by the patient.

[0005] Such gaseous anesthesia administration systems may present several
issues for a medical professional, e.g., a practicing physician, dentist
or podiatist. First, it is important that the face mask and its
associated tubing do not impede access by the dentist or other medical
professional to the person's mouth. Anesthesia masks typically used in
general surgery cover both the nose and mouth, and include tubes that
extend into the patient's throat. Such mask systems cannot be used when
access to the patient's mouth is required. Second, the patient may exhale
significant quantities of the anesthetic, which can then enter the
atmosphere of the dental office where it can be inhaled by dentists and
dental assistants. Therefore such systems also may include means for
recovering the exhaled anesthetic gas so that the gas does not enter the
general atmosphere of the office. However such gas recovery systems may
be cumbersome. It is important that such gas recovery systems do not
block or impede access to the person's mouth. Third, in some cases the
medical professional may administer a blend of oxygen and an anesthetic
gas, or may administer oxygen alone. It therefore would be desirable to
provide a system that could administer only oxygen, or only gaseous
anesthesia, or a mixture of oxygen and gaseous anesthesia. Fourth, it is
desirable to monitor the gases being exhaled by the patient; in
particular the medical professional may wish to monitor the level of
exhaled carbon dioxide. It therefore would be desirable to provide a
means to sample the gases exhaled by the individual receiving gaseous
treatment during the course of the medical procedure. In addition, it
would be desirable to provide a face mask and anesthesia administration
system that is simple to manufacture, is easy for the medical
professional, e.g., an anesthesiologist, physician, dentist, or
podiatrist, to operate, and is comfortable for the person receiving
anesthesia.

SUMMARY OF THE INVENTION

[0006] These and other objects of the invention are met by the face mask
and anesthesia administration system disclosed herein. A face mask is
provided, the face mask being configured for placement over the nose but
not the mouth of a person. The face mask has an inner surface and an
outer surface, such that when the face mask is placed over the person's
nose a nasal breathing plenum is defined between the person and the inner
surface of the face mask in the region surrounding the person's nose. The
face mask includes a gas inlet means, a gas outlet means, and one or
more, preferably one, gas sample access means; preferably the gas inlet
means, gas outlet means, and gas sample access means are each integrally
formed with the mask in a one-piece construction. The gas inlet means is
connectable to a source of gas to be administered to the person. The gas
outlet means is connectable to a means for removing gas from the nasal
breathing plenum. The gas sample access means is connectable to a system
that can analyze a gas sample for carbon dioxide content, or other
components of possible interest. The face mask is advantageously
configured so that in use the connections to the gas source, the gas
removal system and the gas sample analyzing system are each oriented away
from the person's mouth where the medical professional will be working.
The face mask may also be disposable, so that the mask may be a
single-use product.

[0007] In operation, the gas mask is placed over the patient's nose, and
connected to a source of gas to be administered. If gaseous anesthesia is
to be included in the gas to be administered, the face mask also will be
connected to a gas removal system. The gas is then administered to the
patient, and the medical professional proceeds with the medical or dental
procedure in the person's mouth. During the procedure the gas in the
nasal breathing plenum can be accessed, if desired, to monitor the
composition of the gas, such as for carbon dioxide or other components of
interest.

[0008] The gas mask of the invention is versatile and permits monitoring
of gas in the nasal breathing plenum and administration of various gases
to the patient as needed. For example, the patient may be administered
supplemental oxygen alone or a mixture of oxygen and nitrous oxide. In
addition, the gas mask may be swapped out for an anesthesia mask
(covering both the nose and mouth) should the patient require such
treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The concept of the present invention may be more readily understood
by reference to the drawings herein, wherein like reference numerals
indicate like parts, and wherein

[0010]FIG. 1 is a perspective view of a face mask for use in the present
invention;

[0011]FIG. 2 is a front elevation view of a face mask for use in the
present invention;

[0012]FIG. 3 is a rear elevation view of a face mask for use in the
present invention;

[0013]FIG. 4 is a right side elevation view of a face mask for use in the
present invention;

[0014]FIG. 5 is a left side elevation view of a face mask for use in the
present invention;

[0015]FIG. 6 is a top plan view of a face mask for use in the present
invention;

[0016]FIG. 7 is a bottom plan view of a face mask for use in the present
invention;

[0017]FIG. 8 is a perspective view of a face mask for use in the present
invention, showing the mask with connections to a gas source and a gas
removal system, and further showing a means for securing the mask to an
individual;

[0018] FIG. 9 is an exploded perspective view of the face mask for use in
the present invention; and

[0019] FIG. 10 is a perspective view of a face mask for use in the present
invention shown in use on a patient.

[0020] FIGS. 11A and 11B are perspective views of a face mask for use in
the present invention;

[0021] FIGS. 12A-12C are front elevation views of a face mask for use in
the present invention;

[0022]FIG. 13A is a rear elevation view of a face mask for use in the
present invention;

[0023]FIG. 13B is a rear elevation view of a face mask for use in the
present invention;

[0024]FIG. 14 is a right side elevation view of a face mask for use in
the present invention;

[0025]FIG. 15 is a left side elevation view of a face mask for use in the
present invention;

[0026]FIG. 16A is a top plan view of a face mask for use in the present
invention;

[0027]FIG. 16B is a top plan view of a face mask for use in the present
invention;

[0028]FIG. 17 is a bottom plan view of a face mask for use in the present
invention;

[0029]FIG. 18 is a perspective view of a face mask for use in the present
invention, showing the mask with connections to a gas source and a gas
removal system, and further showing a means for securing the mask to an
individual;

[0030]FIG. 19 is an exploded perspective view of the face mask for use in
the present invention; and

[0031] FIG. 20 is a perspective view of a face mask for use in the present
invention shown in use on a patient.

DETAILED DESCRIPTION OF THE INVENTION

[0032] As illustrated in the figures, a face mask 10 for use in the
present invention comprises a cup-shaped shell 12 having a curved wall 14
terminating at a periphery 16. Curved wall 14 of shell 12 is configured
to fit over a person's nose while providing access to a person's mouth.
Shell 12 is provided about the periphery 16 of curved wall 14 with a
flexible peripheral seal 20. Seal 20 has a forward edge 22 that engages
the periphery 16 of curved wall 14 in substantially air-tight engagement,
and a rearward edge 24 that engages the face of the person to whom the
gas is administered. Seal 20 preferably is made of a material that has
sufficient flexibility and resiliency to provide a comfortable seal
against the person's face, while having sufficient firmness to support
shell 12 in operable relation to the person being treated. The inner
surface of seal 20, the inner surface of curved wall 14, and the surface
of the person's face when the mask is applied together define a region in
space referred to herein as the nasal breathing plenum.

[0033] Curved wall 14 of shell 12 is provided with gas inlet means 30
comprising gas inlet port 32 (FIG. 3) from which extends gas inlet
channel 34. Gas inlet channel 34 is advantageously sized and dimensioned
to allow for connection to standard connectors typically used with oxygen
and anesthesia tubing, such as gas inlet tubing 80 (FIG. 8). For example,
in one embodiment gas inlet channel 34 may have an outer diameter of
about 15 mm. Gas inlet means 30 can be used to introduce any desired gas
from a gas source. The gas can be oxygen, an anesthetic such as nitrous
oxide, or a mixture of the two, as will be known to those skilled in the
art Gas inlet tubing 80 is connected at one end to gas inlet channel 34,
and at its other end to a gas source as in well known in the art (not
shown). In a preferred embodiment, gas inlet channel 34 has no bends or
elbows that would block or impede the flow of gas from the tubing 80
through inlet port 32 in curved wall 14 of shell 12 to reach the person
being treated.

[0034] Where gas inlet channel 34 has an outer diameter of, for example,
about 15 mm, it may be connected to gas inlet tubing having a 15 mm ID
opening at one end (the mask end) and a dimension at its distal end
appropriate for connection to standard connectors to a gas source. For
example, in one embodiment, the distal end of the gas inlet tube has an
inner diameter of about 22 mm and may be connected to a gas source having
a appropriately dimensioned supply connector.

[0035] In certain embodiments, there will be multiple gas sources
available to the professional, e.g., oxygen and nitrous oxide, preferably
rapidly interchangeable from one gas supply to another, or to a blend of
gases, via, for example, appropriate shut-off valves.

[0036] In certain situations, it may be necessary to administer full
anesthesia to the patient, in which case the gas mask may be swapped out
for an anesthesia mask that covers both the nose and the mouth and that
has a gas inlet channel of the same diameter as the gas inlet channel 34
of the inventive mask.

[0037] Curved wall 14 of shell 12 is further provided with gas outlet
means 40 comprising gas outlet port 42 from which extends gas outlet
channel 44. Gas outlet channel 44 is advantageously sized and dimensioned
to allow for connection to standard tubing that will convey gases to a
gas recovery system if desired. Gas outlet means 40 may be sized somewhat
smaller than gas inlet means 30, e.g., about 10 mm outside diameter (OD),
to facilitate a positive pressure within the nasal breathing plenum
define by mask 10. If the gas being administered is only oxygen, then
there will be no need to recover the exhaled gases, in which case the gas
outlet channel can be provided with a cap 47 (FIG. 4), plug, or similar
stopper. Alternatively, if the gas administered to the person includes
gaseous anesthesia, then gas outlet channel can be connected to a gas
outlet tubing 82 that can convey gas from the nasal breathing plenum to a
gas recovery means such as are known in the art. In a preferred
embodiment, gas outlet channel 44 has no bends or elbows that would block
or impede the flow of gas from the nasal breathing plenum to the outlet
tubing 82.

[0038] It is an advantage of the present invention that shell 12 does not
include any vents, or perforations, that would allow the escape of
anesthetic gases into the general atmosphere of the room in which the
procedure is being performed, so that such gases will not affect other
persons in the room. The non-vented or perforated shell also allows for
the administration of positive pressure oxygen should the patient's
oxygen saturation decrease.

[0039] It is another advantage of the present invention that gas inlet
channel 34 and gas outlet channel 44 are oriented in such a manner that
gas inlet tubing 80 and gas outlet tubing 82 are oriented away the
patient's mouth and away from the working area of the medical
professional performing the procedure on the patient. In the illustrated
embodiment, the inlet channel 34 and the outlet channel 44 are oriented
substantially vertically and on the top facing portion of shell 12, so
that inlet tubing 80 and outlet tubing 82 are directed substantially
vertically upward, away from the patient's mouth and away from the region
where the medical professional is working.

[0040] In a preferred embodiment, the mask 10 is further provided with a
sampling access means 50 to allow sampling of the gas in the nasal
breathing plenum. In the embodiment illustrated in FIGS. 1-10, curved
wall 14 of shell 12 is provided with a sampling port 52 from which sample
access channel 54 extends substantially horizontally, i.e., forward from
the patient. In an alternative embodiment, as shown in FIGS. 11-20,
curved wall 14 of shell 12 is provided with a sampling port 52 from which
sample access channel 54 extends substantially vertically, i.e., in a
direction that is substantially parallel to outlet channel 44 and inlet
channel 34. Sampling port 52 and sampling access channel 54 can be
significantly smaller in diameter than the gas inlet and outlet ports and
the gas inlet and outlet channels, respectively. In a procedure in which
sampling will not be performed, sampling access channel 54 can be
provided with a cap 56 (FIG. 4) or other suitable closure means to
maintain the pressure within the nasal breathing plenum. In a procedure
in which sampling of the gas in the plenum will be performed, cap 56 is
removed and a sampling tubing (not shown) can be affixed to the open end
of sampling access channel 54. As is known in the art, such tubing can be
provided with a valve which can be opened to allow sampling of the gas in
the nasal breathing plenum when desired, and closed when sampling is not
being done. Sampling channel 54 is positioned on curved wall 14 of shell
12 to facilitate easy access by the medical professional performing the
procedure. At the same time, the short length of sample access channel 54
relative to gas inlet channel 34 and gas outlet channel 44 ensures that
the sampling access channel 54 will not be in the medical professional's
way as work is being performed in the person's mouth.

[0041] The embodiments shown in FIGS. 12C and 16B include more than one
gas sample access means 50, where the channel 54 of access means 50 are
depicted in FIG. 16B as capped with cap 56.

[0042] Mask 10 can be secured to the individual by means of a head strap
such as is known in the art. To facilitate such securement, shell 14 is
provided on the outer surface of curved wall 14 with one or more
forwardly projecting lugs 60 to which a head strap may be secured.
Advantageously two lugs 60 can be used, one on each side of curved wall
14. As shown in FIG. 10, strap 65 is provided with perforations 67. Strap
65 preferably is made of an elastic material. Selected perforations 67 of
strap 65 are placed over lugs 60, and the strap 65 is placed against the
back of the wearer's head, to provide a secure yet comfortable fit of
mask 10 to the user's face.

[0043] Shell 12 of mask 10 is preferably a plastic material that can be
formed into a desired shape by standard molding procedures such as
injecting molding. The lack of any bends or elbows in any of the gas
inlet channel, gas outlet channel, and sample access channel facilitates
ease of injection molding and removal of the finished part from the mold.
In a preferred embodiment shell 12 is transparent, more preferably
colorless, so that the attending medical professional can monitor a
patient's breathing by observing the appearance and disappearance of
condensed breath vapors on the inner surface of shell 12. In addition,
the design of the mask is free of valves or other moving parts that would
complicate both manufacture and use of the mask

[0044] FIG. 9 is an exploded view of mask 10 to facilitate understanding
of the assembly of shell 12, peripheral seal 20 and cap 56. Shell 12
includes curved wall 14 terminating at a periphery 16, the periphery 16
including integrally molded collar 18 that circumscribes periphery 16.
Peripheral seal 20 has a forward edge 22 including a circumferential lip
23 adapted to engage molded collar 18 of shell 12 to provide a
substantially air-tight seal therebetween. Peripheral seal 20 can be
provided in larger and smaller sizes to better adapt the face mask 10 to
the size of the person to be treated. Cap 56 fits across the open end of
sample access channel 54, to which it may be removably secured by
conventional securement means such as lateral tabs 58 that facilitate
ease of removal and replacement of cap 56.

[0045] FIG. 10 illustrates a method of using the face mask of the present
invention, in which the face mask 10 of the present invention is secured
to a patient, shown in phantom lines. Face mask 10 covers the patient's
nose to define a nasal breathing plenum between the inner surface of the
mask and the patient. Face mask 10 is secured to the patient by strap 65,
which extends behind the patient's head and is removably secured to face
mask 10 by placing perforations 67 over forwardly projecting lugs 60. Gas
to be administered to the patient passes through gas inlet tubing 80
through gas inlet channel 34 and gas inlet port 32 of gas inlet means 30
to reach the nasal breathing plenum between the inner surface of face
mask 10 and the patient's face. If the gas administered is oxygen or
another gas that can be released to the environment, then gas outlet
channel can be provided with cap 47. If the gas provided to the patient
includes a gaseous anesthetic or other gas which should not be released
to the environment, then gas outlet channel 44 will be connected to gas
outlet tubing 82, such that gas in the nasal breathing plenum which
should not be released to the environment will pass through gas outlet
port 42 of gas outlet means 40, through gas outlet 44 channel and into
gas outlet tubing 82, from which it can be conveyed to a gas scavenger
system or other gas containment system such as is known in the art. The
rate of flow of gas into the face mask 10, the rate of flow out of the
face mask 10, and the relative sizes of the inlets and outlets will be
set and configured so as to remain a positive pressure of gas within the
nasal breathing plenum. It will be observed that the face mask 10 of the
present invention does not require valves at the gas inlet and outlet
ports, and does not require cannulae to be inserted into the nares of the
patient, thereby facilitating patient comfort and compliance with the
system. In addition, the face mask 10 affords the medical professional
ready access to the patient's mouth for dental or other procedures, and
orients he inlet and outlet tubing 80, 82 vertically upward to be out of
the way during the course of the procedure

[0046] If it is desired to sample the gas within the nasal breathing
plenum, such as to monitor the level of carbon dioxide or other gases,
then cap 56 can be removed from sampling access channel 54, and standard
tubing supplied with a luer lock mechanism can be affixed to sampling
access channel 54 to allow samples of the gas in the plenum to be
transported to a gas analyzer (not shown) as is known in the art.